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Found 21910 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID: 674416 (history)  
Age: 0.5  
Gender: Female  
Location: Colorado  
Vaccinated:2016-10-10
Onset:0000-00-00
Submitted: 2016-12-22
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS FY7FK / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI611AA / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N44209 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M025565 / 2 - / PO

Administered by: Public       Purchased by: Public
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: No Adverse reaction FLUZONE QUADRIVALENT dose of 0.5ml was administered (discovered on 12/22/2016).


VAERS ID: 674427 (history)  
Age: 77.0  
Gender: Male  
Location: Arkansas  
Vaccinated:2016-12-09
Onset:2016-12-14
   Days after vaccination:5
Submitted: 2016-12-22
   Days after onset:8
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N97935 / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Injection site discomfort, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Reported local injection discomfort that went away, shoulder pain returned on 12/14 and has not improved to date although will improve throughout day.


VAERS ID: 674428 (history)  
Age: 75.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2016-12-09
Onset:2016-12-15
   Days after vaccination:6
Submitted: 2016-12-22
   Days after onset:7
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N97935 / 0 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Arthralgia, Injection site discomfort, Joint range of motion decreased
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Reported local injection discomfort then went away, shoulder joint pain returned on 12/15. This has slowly improved, but pt still has limited range of motion to date.


VAERS ID: 674429 (history)  
Age: 0.33  
Gender: Male  
Location: Massachusetts  
Vaccinated:2016-12-20
Onset:2016-12-21
   Days after vaccination:1
Submitted: 2016-12-22
   Days after onset:1
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C5215AA / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N34937 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M007301 / 1 - / PO

Administered by: Private       Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever 102.4 R after imms no soreness, fussiness, or redness at site.


VAERS ID: 674929 (history)  
Age: 66.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2016-12-16
Onset:2016-12-17
   Days after vaccination:1
Submitted: 2016-12-22
   Days after onset:5
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) / SANOFI PASTEUR N47827 / 0 RA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH UI691AB / 0 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt. received PREVNAR and FLUZONE on 12/16/16, he came in on 12/22 and said the PREVNAR site has been itchy since Monday and noticed today that there was a rash spread over the area the size of a baseball. I recommended he take BENADRYL and apply hydrocortisone and call MD if not improved tomorrow.


VAERS ID: 674070 (history)  
Age: 70.0  
Gender: Male  
Location: Foreign  
Vaccinated:2016-10-04
Onset:2016-10-20
   Days after vaccination:16
Submitted: 2016-12-21
   Days after onset:62
Entered: 2016-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER L36N / 0 AR / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J86950 / 0 AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Eczema, Malaise, Pruritus, Respiratory tract infection, Restlessness
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac dilatation (started years before); Cluster headache (started years before); COPD; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Vaccination (unspecified)
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2016544779

Write-up: This is a spontaneous report from a contactable physician via company representative. A 70-year-old male patient received first dose of PREVENAR 13 (Lot J86950), intramuscular in upper arm at 0.5 ml single for immunization on 04Oct2016 at 12:34. The patient medical history included right heart dilatation and cluster headache, both started years before the report and ongoing , ongoing hypertension arterial and ongoing chronic obstructive pulmonary disease (COPD) .Previous adverse reactions after vaccinations were not known. It was unknown whether the patient had allergies. Concomitant medication included first dose INFLUVAC (Lot L36N) at 1 DF single intramuscular in upper arm for immunization on 04Oct2016 at 12:34. On 20Oct2016 the patient experienced eczema, cough and malaise assessed as non-serious. On 20Oct2016 at 08:20 he had pruritus, respiratory infection and restlessness. There were no relevant tests. Eczema, cough and malaise spontaneously regressed after 2 weeks. Patient recovered from all the events on an unknown date. A control was performed by general practitioner at home. The causality between eczema, cough and malaise and pneumococcal 13-val conj vac (dipht crm197 protein) was reported as probably. The physician considered that the relationship of the events pruritus and eczema to treatment with vaccine was possibly related. Follow-up (16Dec2016): New information received from the same physician includes: vaccination details (route, anatomical location, lot, vaccination date), events updated (pruritus, respiratory infect, restlessness) medical history,assessment, case seriousness. Follow-up attempts completed. No further information expected.; Sender''s Comments: Based on the information currently available, the company considers that there is not a close temporal relationship between the occurrence of the events and the administration of PREVENAR 13 to suggest a causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 674071 (history)  
Age: 0.33  
Gender: Male  
Location: Foreign  
Vaccinated:2016-11-08
Onset:2016-11-12
   Days after vaccination:4
Submitted: 2016-12-21
   Days after onset:39
Entered: 2016-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Adenovirus test positive, Anxiety, Blood pressure increased, Cytomegalovirus test positive, Echocardiogram normal, Eye movement disorder, Flatulence, Hemiparesis, Lumbar puncture normal, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction positive, Screaming, Seizure, T-lymphocyte count normal, Ultrasound scan normal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypertension (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations: 10029436~DTaP+IPV+HepB+Hib (Foreign)~~0.00~Patient|10029436~Pneumo (Prevnar13)~~0.00~Patient
Other Medications:
Current Illness: Hypertension arterial; Immunodeficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Cephalhaematoma
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result: 120/80, Test Result Unit: mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result: increased, Test Result Unit: mmHg; Test Name: CMV IgG antibody; Result Unstructured Data: Test Result: 29.3 U/mL; Test Name: PCR; Result Unstructured Data: Test Result: positive; Test Name: PCR; Result Unstructured Data: Test Result: positive
CDC Split Type: DEPFIZER INC2016586227

Write-up: This is a spontaneous report from a contactable physician received from Regulatory authority. Regulatory authority report number DE-PEI-PEI2016099939. A 4-month -old male patient, was vaccinated with the second dose of PREVENAR 13 and the INFANRIX HEXA, both for prophylactic vaccination, via an unspecified route of administration on 08Nov2016. Concomitant medication was not reported. The patient in the past had received other two doses of diphtheria vaccine, haemophilus influenza type b vaccine, hepatitis b vaccine, pertussis vaccine, polio vaccine, tetanus vaccine and one dose of pneumococcal 13-val conj vac (dipht crm197 protein) and all had been tolerated. Relevant medical history included fluid intake reduced, subclinical gastroenteritis with evidence of adenoviruses in the stool, CMV infection, immunodeficiency, hypertension arterial under prednisolone therapy, cephalhaematoma surgically drained and sleepiness. On 12Nov2016 the patient developed acute disseminated encephalomyelitis. The patient was hospitalized for the event on the same date and was discharged on 01Dec2016. The outcome of the event was reported as not recovered. The diagnosis was confirmed by CMV: IgG-AK reactive: 29.3 U/mL, Adenovirus DNA: PCR positive and CMV PCR urine: positive. The inpatient admission was performed under severe neurological abnormalities. The quickly performed MRI indicates of a multilocular brightening, such as in the case of encephalitis, no indication of cerebral compression. The liquor puncture was normal. Nevertheless, the physician immediately started an antibiotic therapy with cefotaxime, gentamicin and aciclovir. There was no indication of an acute infection, neither culturally nor serologically. In addition the patient was treated from the 13Nov2016 with dexamethasone, which was replaced on the next day by methylprednisolone and this was reduced from 19Nov2016 and finally dropped off on 21Nov2016. To exclude tubercular encephalitis a Quantiferon test under the steroid therapy was performed, which results in the absence of stimulatory T-lymphocytes or insufficient variation of T-lymphocytes in the sample. An immune defect was also to be considered due to the severity of the clinic in case of missing minimally signs of infection. In the review, the most likely diagnosis was an acute demyelinating encephalomyelitis, which could have occurred after vaccination or after gastroenteritis by adenovirus. In addition, a CMV-Antibody constellation was found, which could be a result of a CMV infection. The blood pressure in the patient, was constant at 120/80 mm Hg during the long-term therapy with prednisolone. The echocardiography result was normal, age-appropriate. There was also meteorism and scream attacks. The sonographical examination was normal. The scream attack could be an expression of neurologic symptoms. In the following course these symptoms improved, but patient was awake and with increasingly anxiety. Fixation eye movements were difficult and exhausting, but improved in the following course. Fluid intake improved. Phenobarbital was given for anxiety and suspicion of seizure. The patient received Midazolam in low dosage as continuous flow infusion from 13Nov2016. The patient becomes much quieter and gains a normal day/night rhythm. Neurologically, there was also a motor weakness of the right half of the body, which improved slowly in course of action, but remained in the arm.


VAERS ID: 674075 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2016-12-12
Onset:2016-12-19
   Days after vaccination:7
Submitted: 2016-12-21
   Days after onset:2
Entered: 2016-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER DM020A / 0 LA / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KS08R / 1 RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1049 / 1 LA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15L01A / 1 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? Yes
   Date died: 2016-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 19.1;10016558~Vaccine not specified (no brand name)~~0.00~Patient|19.1;10016558~Hib (ActHIB)~~0.00~Patient|19.1;10016558~Pneumo
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Date: 20161212; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.9, Test Result Unit: Centigrade
CDC Split Type: JPPFIZER INC2016588352

Write-up: This is a spontaneous report received from Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labor and Welfare (MHLW). Regulatory authority report is number v16100933. A contactable physician reported that a 3-month-old male patient received second dose of subcutaneous PREVENAR 13 (Lot # 15L01A, Exp. Date 31Oct2018) at 0.5 ml single dose in the right arm, first dose of SQUAREKIDS(Lot # DM020A) at 1 DF single in the left arm, second dose of subcutaneous HEPTAVAX (Lot # 9KS08R) at 1 DF single in the right arm, and second dose of subcutaneous ACT-HIB (Lot # M1049) at 1 DF single in the left arm, all in the afternoon of 12Dec2016 for immunisation. The patient had no significant family history. The patient had pyrexia after receiving the first vaccination with pneumococcal 13-val conj vac (dipht crm197 protein), hepatitis b vaccine and haemophilus influenza type b vaccine on 14Nov2016. The patient''s body temperature immediately before the vaccination on 12Dec2016 was 36.9 centigrade. After receiving vaccination on 12Dec2016, the patient had no problem and he was alive at 10:00 p.m. on 18Dec2016 at the latest. However, on 19Dec2016 at 3:32 am, the patient presented to the reporting hospital in a state of cardiopulmonary arrest on arrival (CPAOA). The patient died on 19Dec2016. The patient died on 19Dec2016. It was not reported if an autopsy was performed. The reporting physician classified this case as serious due to the patient''s death. The reporting physician considered that the causal relationship between the event and the vaccinations was unassessable, and provided other etiology of suffocation or sudden infant death syndrome (SIDS) for the unexplained abnormal death. The reporting physician commented that the causal relationship to the vaccinations was completely unknown.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-2016589900 same patient and product, different event; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 674078 (history)  
Age: 1.25  
Gender: Male  
Location: Foreign  
Vaccinated:2011-01-31
Onset:2011-02-04
   Days after vaccination:4
Submitted: 2016-12-22
   Days after onset:2148
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72FA598A / - UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0793Y / - UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E83113 / - UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? Yes
   Date died: 2011-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131612NZL005945

Write-up: Information was obtained on a request by the Company from the agency (agency # not provided) via a Case Line Listing concerning a 15 month old male patient. The patient had no pre-existing renal disease, pre-existing hepatic disease, known allergy, other chemicals, nutritional supplements or other unspecified medical conditions. Information about recent therapy, transfusion, X-ray with contrast media and familial were unknown. On 31-JAN-2011, the patient was vaccinated with a dose of MMRII (rHA) (lot # 0793Y, batch# N2746, 0.5 ml) subcutaneously for immunization against measles-mumps-rubella. Other therapy included HIBERIX (batch# A72FA598A, 0.5 ml, intramuscular) as need for immunization against other specified single viral diseases and pneumococcal vaccine (unspecified) (batch# E83113, 0.5 ml, intramuscular) as need for immunization against other single bacterial diseases. On 04-FEB-2011, the patient experienced sudden death (severe). The cause of the death was unclassifiable. Dechallenge was reported as unknown and no rechallenge was performed. The reporter considered these the causality between the event and MMRII was unclassifiable. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.


VAERS ID: 674079 (history)  
Age: 1.25  
Gender: Male  
Location: Foreign  
Vaccinated:2015-07-13
Onset:2015-07-13
   Days after vaccination:0
Submitted: 2016-12-22
   Days after onset:528
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K1357 / - UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. K011902 / - UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J52867 / - UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Cyanosis, Febrile convulsion
SMQs:, Anaphylactic reaction (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131612NZL010311

Write-up: Information was obtained on a request by the company from the agency (HA # CARM117164) via a Case Line Listing concerning a 15 months old male patient. The patient''s recent surgery, transfusion, X-ray with contrast media, other chemicals, nutritional supplements, known allergy and familial condition were unknown. On 13-JUL-2015, the patient was vaccinated with one dose of M-M-R II (HAS) (batch/lot # K011902, expiry date not reported) 0.5 ml, subcutaneously for immunization against measles-mumps-rubella. On the same day, he received ACTHIB (batch/lot # K1357, expiry date not reported) 0.5ml, intramuscularly and PREVENAR 13 (batch/lot J52867 expiry date not reported) 0.5ml via intramuscularly for immunization. On the same day in less than 12 hours of vaccination, the patient experienced severe cyanosis and severe febrile convulsion and was hospitalized on an unknown date. Outcome of the events was reported as recovered without sequelae (dechallenge: definite improvement). No rechallenge was performed. The reporting agency considered cyanosis possibly related and febrile convulsion probably related to M-M-R II. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.


VAERS ID: 674081 (history)  
Age: 1.0  
Gender: Female  
Location: Foreign  
Vaccinated:2015-12-10
Onset:2015-12-10
   Days after vaccination:0
Submitted: 2016-12-21
   Days after onset:377
Entered: 2016-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M13114 / 0 RL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: C-reactive protein, Diarrhoea, Haemoglobin normal, Platelet count normal, Pyrexia, Thrombocytopenia, Urine analysis, Vaccination complication, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Date: 20151210; Test Name: Body temperature; Result Unstructured Data: Test Result: up to 39.6, Test Result Unit: Centigrade; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 2.36; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 11.5; Test Name: Platelet count; Result Unstructured Data: Test Result: 215; Test Name: Urine analysis; Result Unstructured Data: Test Result: 6.2; Test Name: Leucocyte count; Result Unstructured Data: Test Result: 5.7
CDC Split Type: PLPFIZER INC2016584053

Write-up: This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is PL-URPL-N54/2016. The reporter is contactable to HA only. A 12-month-old female patient of unspecified race/ethnicity received first dose of PREVENAR 13, (lot number M13114, expiration date Jan2018) on 10Dec2015 08:39 at 0.5 ml single dose in the right thigh intramuscular for immunization. Medical history and concomitant medications were not reported. Lack of post vaccination reaction after previous vaccination. On 10Dec2015 at 5:00 pm the patient experienced fever 38.5-38.9 Centigrade lasting 80 hours and thrombocytopenia - the lowest level of platelets 215 and diarrhea on13Dec2015 at 5.00 pm (3 x loose stool). On the day of vaccination fever up to 39.6 Centigrade. Laboratory data showed on an unspecified date: WBC count 5.7; hemoglobin 11.5; platelet count 215; CRP 2.36. Controlled in hospital pediatric clinic. Urine general 6.2. Diagnosis: fever - suspicion of post vaccination adverse reaction. She received following the recommendation of the emergency room paracetamol and ibuprofen. The fever receded after 3 days (80h). On 13Dec2015 3 times loose stool. From 14Dec2015 without pathological symptoms. Outcome was full recovery on an unspecified date. Health Authority comment: Fever and diarrhea are expected adverse reactions after administration of the vaccine pneumococcal 13-val conj vac (dipht crm197 protein) recognized in its Summary of Product Characteristics. Thrombocytopenia is an unexpected adverse reaction, not listed in the Summary of Product Characteristics. In adverse reaction database untill 09Mar2016 were reported 41 cases of thrombocytopenia following vaccination with pneumococcal 13-val conj vac (dipht crm197 protein). The physician while checking options of adverse reaction - thrombocytopenia, was not sure about this choice, put next to it a question mark. Temporal relationship speaks for a cause-and-effect relation. The reporting person qualified the post vaccination adverse reaction as "mild", but due to the nature of the adverse reaction URPL assessed it as "serious". No follow-up attempts are required. No further information is expected.


VAERS ID: 674351 (history)  
Age: 0.4  
Gender: Female  
Location: Foreign  
Vaccinated:2016-11-11
Onset:2016-11-12
   Days after vaccination:1
Submitted: 2016-12-22
   Days after onset:40
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Insomnia, Intensive care, Neurological examination normal, Opisthotonus, Restlessness, Ultrasound skull
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dystonia (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Date: 201611; Test Name: Neurological examination; Result Unstructured Data: Test Result: normal; Test Date: 20161213; Test Name: Neurological examination; Result Unstructured Data: Test Result: without pathology; Test Date: 201611; Test Name: Ultrasound skull
CDC Split Type: CZPFIZER INC2016593023

Write-up: This is a spontaneous report received from the regulatory authority, Regulatory Authority report Number CZ-CZSUKL-16004128 from contactable physician. A 5-month-old female patient of an unspecified ethnicity received the 2nd dose of PREVENAR 13, via an unspecified route of administration on 11Nov2016 at 0.5 ml, single for immunisation. The patient medical history was not reported and concomitant medications were not reported. The patient was breastfed. No adverse reaction occurred with previous vaccinations. The patient experienced back arched backward, restless, behavior abnormal, stop gurgling, sleeplessness on 12Nov2016 with outcome of unknown. The patient was hospitalized in an intensive care unit for 4 days. The patient underwent lab tests and procedures which included neurological examination on Nov2016 (normal) and on 13Dec2016 (without pathology), and ultrasound skull on Nov2016 (no results provided). According to the neurologist suspected relation between vaccination with pneumococcal 13-val conj vac (dipht crm197 protein) and described reactions.


VAERS ID: 674353 (history)  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-12-07
Submitted: 2016-12-22
   Days after onset:15
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / - UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / - UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / - UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Date: 20161207; Test Name: Body temperature; Result Unstructured Data: Test Result: 39.1
CDC Split Type: GBPFIZER INC2016591397

Write-up: This is a spontaneous report from a consumer via the contactable regulatory authority. Regulatory Authority report number GB-MHRA-ADR 23771553. A 9 weeks old male patient of an unknown race received a single dose of PREVENAR 13, BEXSERO, ROTARIX and DTPA IPV HIB VACCINE, all parenterally, on an unspecified date, for routine childhood immunisation. No relevant medical history or concomitant medication details were provided. On 07Dec2016 the patient experienced fever 39.1 and upset stomach. The events resolved on 08Dec2016. The reporter considered the events to be serious as they were medically significant. The regulatory authority considered the events to be serious for an unspecified reason. No follow up attempts possible. No further information expected.


VAERS ID: 674354 (history)  
Age: 0.25  
Gender: Female  
Location: Foreign  
Vaccinated:2016-11-16
Onset:2016-11-16
   Days after vaccination:0
Submitted: 2016-12-22
   Days after onset:36
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC700C / 0 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R37144 / 0 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, C-reactive protein increased, Culture urine negative, Cyanosis, Electroencephalogram, Gastrooesophageal reflux disease, Hyporesponsive to stimuli, Hypotonia, Laboratory test abnormal, Leukocytosis, Loss of consciousness, Neurological examination normal, Occult blood, Pallor, Pharyngeal erythema, Presyncope, Ultrasound scan abnormal, Upper respiratory tract inflammation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result: 1.4, Test Result Unit: mg/dl; Test Name: Urine culture; Result Unstructured Data: Test Result: negative; Test Name: Chemistry NOS; Result Unstructured Data: Test Result: leukocytosis; Test Name: Neurological examination; Result Unstructured Data: Test Result: negative; Test Name: Echography; Result Unstructured Data: Test Result: Gastroesophageal reflux
CDC Split Type: ITPFIZER INC2016592900

Write-up: This is a spontaneous report received from a contactable physician via the Regulatory Authority. Regulatory Authority report number 388729. A 3-month-old female patient of an unspecified race on 16Nov2016 11:00 received 1st dose of PREVENAR 13 (lot R37144, exp date 30Jun2018) at the right thigh, and 1st dose of INFANRIX HEXA (lot A21CC700C, exp date 31Mar2018) at the left thigh, both intramuscular at 0.5 ml, single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cyanosis, hypotonia, loss of consciousness, pallor and vomiting on 16Nov2016. The events were serious as per hospitalization and described as follows: episode of vomiting followed by pallor, loss of consciousness (about 10 minutes), sub-cyanosis, marked hypotonia. Spontaneous resolution before arrival at the emergency room. Patient was admitted for observation and discharged after two days. Discharge diagnosis: vasovagal crisis. Gastroesophageal reflux. Upper respiratory inflammation. Clinical course: in the morning the patient underwent first vaccination. In the evening, after artificial milky meal, the patient presented an abundant episode of vomiting followed by pallor, loss of consciousness, sub-cyanosis, marked hypotonia, poor responsiveness to external stimuli. Such episodes lasted for about 10 minutes, then slow and gradual clinical improvement with tone and pallor recovery after about 20 minutes. At the emergency room neurological clinical examination was negative. Finding of raise in body temperature and modest pharyngeal hyperemia. Blood chemistry tests showed a leukocytosis decreasing at discharge, C-reactive protein 1.4 mg/dL. During hospitalization, the patient no longer presented similar episodes, referred food regurgitation with no fever. Clinical neurological examination negative. Echo abdomen showed presence of gastroesophageal reflux. Urine culture test negative. Ongoing tests: EEG, occult blood feces, urine culture. No therapy performed: Recommendations at discharge: Riopan 2 ml as needed small and frequent meals. The events recovered on 16Nov2016.


VAERS ID: 674355 (history)  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2016-05-20
Onset:2016-05-21
   Days after vaccination:1
Submitted: 2016-12-22
   Days after onset:215
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14L07A / 0 UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB24AA / 0 - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: C-reactive protein increased, Haematocrit decreased, Haemoglobin normal, Pyrexia, Red blood cell count normal, White blood cell count normal
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 36.7, Test Result Unit: Centigrade; Test Date: 20160520; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.0, Test Result Unit: Centigrade; Test Date: 20160521; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.7, Test Result Unit: Centigrade; Test Date: 20160708; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.9, Test Result Unit: Centigrade; Test Date: 20160709; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.8, Test Result Unit: Centigrade; Test Date: 20160710; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.5, Test Result Unit: Centigrade; Test Date: 20160521;
CDC Split Type: JPPFIZER INC2016339263

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative from regulatory authority under the regulatory authority report number of V16100309 and V16100310. A 2-month-old female patient received, on 20May2016 at 15:50, the first dose of PREVENAR 13, (Lot. 14L07A, Expiration date: 31Oct2017) subcutaneously, at 0.5 ml, single dose, for immunization. The patient had no relevant medical history. The patient''s weight at birth was 3024 g. Concomitant medication included ROTARIX, (Lot. AROLB24AA) orally, at 1.5 ml, single dose, received on 20May2016 at 15:50 for the first immunization. In the early morning on 21May2016, the patient experienced pyrexia (38.7 Centigrade). Also, the amount of milk sucked was decreased; thus, the patient was seen by the same pediatrician, who did not see abnormal findings physical examination. The patient was transferred to and admitted to other hospital for intensive examination and treatment. The following laboratory data was obtained: body temperature on 20May2016, before the immunization: 37.0 Centigrade; CRP on 21May2016: 2.5 mg/dl; haematocrit: 29.9 % on 21May2016; haemoglobin: 10.4 g/dl on 21May2016; red blood cell count: 3530000 /mm3 on 21May2016; and white blood cell count on 21May2016: 13100 /mm3. During hospitalization, an unspecified antibiotic was administered to the patient for a period of time. The patient recovered from the events, pyrexia, CRP increased and white blood cell increased on 23May2016. Body temperature was 36.7 Centigrade on an unspecified date. Laboratory test values were normalized and consequently, the patient was discharged from the hospital on 23May2016. The pediatrician classified the events as serious (hospitalization). Then, a 4-month-old patient received, on 08Jul2016 at 16:40, the second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, Lot. 15D01A, Expiration date: 31Mar2018) subcutaneously, at 0.5 ml, single dose, for immunization. Around 13:00 on 09Jul2016, the patient experienced pyrexia (37.8 Centigrade). Laboratory test at the second episode of pyrexia revealed CRP and WBC increased on 09Jul2016. Because the patient seemed relatively lusty, a wait-and-see approach was taken without treatment procedures. On 10Jul2016, the patient seemed lusty. The following laboratory data was obtained: body temperature on 08Jul2016, before the immunization: 36.9 Centigrade, on 09Jul2016: 37.8 Centigrade, on 10Jul2016: 37.5 Centigrade; CRP 1.2 mg/dl on 09Jul2016; haemoglobin: 11.0 g/dl on 09Jul2016; red blood cell count: 3830000 /mm3 on 09Jul2016; and white blood cell count 18700 /mm3 on 09Jul2016. The patient recovered from all events on 14Jul2016. The pediatrician assessed all adverse events as definitely related to PREVENAR 13 and commented as follows: the second (on 08Jul2016) and third (on unknown date) dose of pneumococcal 13-val conj vac (dipht crm197 protein) was administered alone. Pyrexia developed after the second and third administration. Based on a series of episodes, the events were definitely caused by pneumococcal 13-val conj vac (dipht crm197 protein). Follow-up (01Dec2016): Follow-up attempts completed. No further information expected. Follow-up (19Dec2016): New information received from the same contactable physician includes: patient details, ROTARIX was changed from suspect drug to concomitant medication, patient''s clinical course laboratory data and reporter''s assessment. Follow-up attempts completed. No further information expected. Sender''s Comments: A possible contributory role of PREVENAR 13 cannot be completely excluded in the events given temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly


VAERS ID: 674356 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2016-12-12
Onset:2016-12-14
   Days after vaccination:2
Submitted: 2016-12-22
   Days after onset:8
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A030A / 0 UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y089L / 1 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1073 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15M02A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Ammonia normal, Amylase decreased, Aspartate aminotransferase normal, Basophil percentage, Blood albumin decreased, Blood alkaline phosphatase increased, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase increased, Blood creatinine decreased, Blood lactate dehydrogenase increased, Blood phosphorus normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Blood uric acid normal, C-reactive protein increased, Eosinophil percentage, Haematocrit decreased, Haemoglobin normal, Hyperthermia, Laboratory test normal, Lymphocyte percentage, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume normal, Monocyte percentage, Muscle twitching, Neutrophil percentage, Protein total decreased, Pyrexia, Red blood cell count normal, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Biliary system related investigations, signs and symptoms (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? Yes
Previous Vaccinations: ~Pneumo (Prevnar13)~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment:
Diagnostic Lab Data: Test Date: 20161213; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result: 22, Test Result Unit: IU/l; Test Date: 20161213; Test Name: Ammonia; Result Unstructured Data: Test Result: 60; Test Date: 20161213; Test Name: Amylase; Result Unstructured Data: Test Result: 11, Test Result Unit: IU/l; Test Date: 20161213; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: 39, Test Result Unit: IU/l; Test Date: 20161213; Test Name: Basophils; Test Result: 0.6 %; Test Date: 20161213; Test Name: Albumin; Result Unstructured Data: Test Result: 4.1, Test Result Unit: g/dl; Test Date: 20161213; Test Name: Blood alkaline phosphatase; Result Unstructured Data: Test Result: 995, Test Result Unit: IU/l; Test
CDC Split Type: JPPFIZER INC2016584816

Write-up: This is a spontaneous report from a contactable pharmacist and then from a contactable physician of the clinic where the patient received vaccination through Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labour and Welfare (MHLW), regulatory authority report number v16100920. A 3 month-old male patient of an unspecified race received on 12Dec2016 at 14:40 the second dose of PREVENAR 13 (lot 15M02A, expiration date 30Nov2018) at 0.5 ml single, the second dose of ACT-HIB (lot M1073) at 1 dosage form (DF) single, the second dose of BIMMUGEN (lot Y089L) at 1 DF single and the first dose of QUATTROVAC(lot A030A) at 1 DF single, all subcutaneously for immunisation. The patient had no particular medical history or family history, no concomitant medications were reported. The patient had received the first single dose of pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date in 2016 for immunization. The patient''s birth weight was 2860 g. The body temperature before the vaccination on 12Dec2016 was 36.6 degrees centigrade. On 13Dec2016 at 12:00 the patient experienced hyperthermia and convulsion, as reported by the pharmacist and the physician of the clinic where the patient received vaccination. On the same day the patient was hospitalized for the events. However the physician who treated the patient in the hospital diagnosed the event as twitching, not convulsion. The reported clinical course in the hospital: on 13Dec2016, the patient developed a high fever of 40 degrees centigrade and also had slight twitching in association with the high fever. As the fever persisted, the patient visited the reporter''s clinic and was further referred to another hospital for detailed examination. The patient was admitted to that hospital on that day and received treatments. On 13Dec2016 the patient underwent laboratory tests and procedures which included alanine aminotransferase: 22 IU/l (normal range: 10.0-42.0), ammonia: 60 (normal range: 12.0-66.0), amylase 11 IU/l (normal range: 44.0-132.0), aspartate aminotransferase: 39 IU/l (normal range: 13.0-30.0), basophils: 0.6 % (normal range: 0.2-1.4), albumin: 4.1 g/dl (normal range: 4.1-5.1), blood alkaline phosphatase: 995 IU/l (normal range: 106.0-322.0), calcium: 9.5 meq/l (normal range: 8.8-10.1), chloride: 105 meq/l (normal range: 101.0-108.0), blood creatine phosphokinase: 227 IU/l (normal range: 59.0-248.0), creatinine: 0.19 mg/dl (normal range:0.65-1.07), lactate dehydrogenase: 273 IU/l (normal range: 124.0-222.0), Inorganic phosphate: 4.9 mg/dl (normal range: 2.7-4.6), potassium: 4.65 meq/l (normal range: 3.6-4.8), sodium: 136 meq/l (normal range: 138.0-145.0), BUN 6.0 mg/dl (normal range: 8.0-20.0), uric acid 3.3 mg/dl (normal range: 3.5-6.9), C-reactive protein 1.92 mg/dl (normal range: 0.0-0.3), eosinophils 1.6% (normal range: 0.4-8.6), haematocrit 34.4% (normal range: 40.7-50.1), haemoglobin 10.9 g/dl (normal range: 13.7-16.8), lymphocytes 30.3% (normal range 18.2-47.7), mean cell haemoglobin 26.6 pg (normal range: 27.5 -33.2), mean cell haemoglobin concentration at 31.7% (normal range: 31.7-36.3), mean cell volume at 83.9 (normal range 83.6-98.2), monocytes at 6.4 % (normal range: 3.3-9.0), neutrophils 61.1 % (normal range: 42.2-75.0), protein total 5.8 g/dl (normal range: 6.6-8.1), red blood cell count 4100 10 3/mm3 (normal range: 4350-5550 103), white blood cell count 6700/mm3 (normal range 3300-8600). The patient''s physician of the hospital where the patient was hospitalized stated that the patient presented only twitching, not convulsion, according to his family member. The patient became afebrile spontaneously, and on 14Dec2016, the patient was discharged with no recurrence of pyrexia or convulsion and favorable systemic condition. The events were resolving. The reporting physician classified the events as serious (hospitalization) and assessed them as causally related to pneumococcal 13-val conj vac (dipht CRM197 protein). He comment


VAERS ID: 674357 (history)  
Age: 0.17  
Gender: Male  
Location: Foreign  
Vaccinated:2016-12-16
Onset:2016-12-16
   Days after vaccination:0
Submitted: 2016-12-22
   Days after onset:6
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y092A / - UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1060 / - UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15M02A / - UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB478BA / - - / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Pallor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Date: 20161216; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.2, Test Result Unit: Centigrade
CDC Split Type: JPPFIZER INC2016590319

Write-up: This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labor and Welfare (MHLW). The Regulatory authority report number is v16100926. A 2 month-old male patient of an unspecified race and ethnicity received on 16Dec2016 at 09:20 am for immunisation PREVENAR 13 (lot 15M02A, expiry date 30Nov2018) at 0.5 ml single subcutaneously, ACT-HIB ( lot M1060) at 1 dosage form (DF) single subcutaneously, BIMMUGEN (lot Y092A) at 1 DF single subcutaneously, and ROTARIX (lot AROLB478BA) at 1 DF single orally. Body weight at birth: 2745 grams. Laboratory findings included body temperature: 36.2 centigrade on 16Dec2016 before of vaccination. The patient medical history and concomitant medications were not reported. On 16Dec2016, at 10:30, the patient was back home and received breast feeding. At 11:20, he suffered from vomiting, and complexion ill was also noted. At 11:40, on the hospital visit, the patient experienced cardio-respiratory arrest. At around 12:20, by ambulance, the patient was emergently transported to another hospital and then hospitalized. Outcome of all the events was unknown. Causality between the events and the suspect vaccines was unknown; meanwhile no other possible factors was considered.


VAERS ID: 674358 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2016-11-11
Onset:0000-00-00
Submitted: 2016-12-22
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchoscopy, Computerised tomogram, Condition aggravated, Cough, Culture negative, General symptom, Mycobacterium tuberculosis complex test negative, Pneumonia, Pulmonary tuberculosis, Pyrexia, Respiratory disorder, Somnolence, Spirometry
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Persistent cough
Diagnostic Lab Data: Test Name: Culture; Comments: RX (unknown date): No results provided; Spirometry (unknown date): No results provided CT (unknown date): No results provided; Bronchoscopy (unknown date): No results provided; Test Name: Tuberculosis test; Comments: RX (unknown date): No results provided; Spirometry (unknown date): No results provided; CT (unknown date): No results provided Bronchoscopy (unknown date): No results provided
CDC Split Type: MXPFIZER INC2016593865

Write-up: This is a spontaneous report from a contactable physician and received from a Pfizer Colleague. A 21-year-old male patient of an unspecified ethnicity received PREVENAR 13 via an unspecified route of administration at single dose on 11Nov2016 for immunisation. Medical history included cough. The patient''s concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, acute respiratory, fever, attack to general state, somnolence, persistent cough was exacerbated from being vaccinated. The outcome of the events was unknown. The patient was hospitalized for pneumonia, acute respiratory event, fever, attack to general state, and somnolence from 28Nov2016 to an unknown date. The patient underwent lab tests and procedures which included: culture and mycobacterium tuberculosis complex test, both negative. On an unknown date Rx, Spirometry, CT and bronchoscopy were performed with no results provided. As a result of acute respiratory event, fever, attack to general state, somnolence, he received Levofloxacin. Patient''s admission diagnostic was: probable pulmonar tuberculosis, to discard pneumonia due other causes.; Sender''s Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 677528 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-12-07
Submitted: 2016-12-22
   Days after onset:15
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / - UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / - UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / - UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: On 7-DEC-2016, Body temperature was reported as 39.1 (unit not provided)
CDC Split Type: GB2016188566

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of fever in a 9-week-old male patient who received BEXSERO. Co-suspect products included ROTARIX, DTPa-IPV +Hib and PREVENAR 13. On an unknown date, the patient received BEXSERO (parenteral), ROTARIX (parenteral), DTPa-IPV +Hib vaccine (parenteral) and PREVENAR 13 (parenteral). On 7th December 2016, less than a year after receiving BEXSERO, ROTARIX and DTPa-IPV+Hib vaccine and an unknown time after receiving PREVENAR 13, the patient experienced fever (serious criteria other) and upset stomach (serious criteria other). On 8th December 2016, the outcome of the fever and upset stomach were recovered/resolved. It was unknown if the reporter considered the fever and upset stomach to be related to BEXSERO, ROTARIX, and DTPa-IPV+Hib vaccine. Additional information: The age vaccination was not provided. Initial information was received from physician via regulatory authority on 20th December 2016: Fever and upset stomach.


VAERS ID: 673963 (history)  
Age: 68.0  
Gender: Female  
Location: Virginia  
Vaccinated:2016-12-16
Onset:2016-12-16
   Days after vaccination:0
Submitted: 2016-12-21
   Days after onset:5
Entered: 2016-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N16561 / 0 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Ear swelling, Injection site rash, Local swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: RASH~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications: VITAMINS
Current Illness: N/A
Preexisting Conditions: PREVIOUS ALLERGY AT SITE OF FLU VACCINE, REPORTED TO CDC PER PATIENT
Diagnostic Lab Data:
CDC Split Type:

Write-up: RASH AT SITE ON RIGHT ARM LATER SPREAD DOWN ARM, SOME SWELLING OF/AROUND THE EAR/NECK, CALLED MD, PATIENT TAKING ZYRTEC AND ZANTAC AS WELL AS RX TRIAMCINOLONE 0.025% CREAM.


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